Composition

ABSTRACT

The invention relates to non-aqueous dentrfrice compositions comprising a surfactant system. The surfactant system consists of a combination of surfactants i.e. a betaine and a taurate surfactant; or a betaine and an alkyl sulphate surfactant; or a betaine, a taurate and an alkyl sulphate surfactant.

FIELD OF THE INVENTION

The present invention relates to a composition in particular to anon-aqueous dentifrice composition comprising a novel surfactant system.In particular the invention relates to a non-aqueous dentifricecomposition comprising a combination of surfactants i.e. a betaine and ataurate surfactant; or a betaine and an alkyl sulphate surfactant; or abetaine, a taurate and an alkyl sulphate surfactant. Such a dentifricecomposition demonstrates pleasant organolpetic properties and is of usein oral care.

BACKGROUND OF THE INVENTION

There are many dentifrice additives which are incompatible with aqueoussystems of typical dentifrice formulations. One way of overcoming thisincompatibility problem is to formulate such additives in a non-aqueous(anhydrous) formulation. However in addition to circumventing the waterincompatibility problem, such formulations must also be successful froma consumer acceptance standpoint and demonstrate, for example,acceptable taste, consistency and adequate foaming on brushing of teeth.

U.S. Pat. No. 3,574,824 (Warner-Lambert) describes an anhydroustoothpaste base comprising inter alia an oil, a combination ofpolyethylene glycols and a non-toxic, non-ionic emulsifier which is amixture of glycerides. U.S. Pat. No. 3,574,824 discloses that anexperimental paste was made using oily liquids, such as vegetable oil orextra light mineral oil, and a suitable surfactant. However when thepaste was brought into contact with water during brushing there wasinsufficient foaming in the oral cavity. This was thought to be due tothe fact that the foaming agent (sodium lauryl sulphate) was “hindered”in the anhydrous mass and was unable to concentrate at the air-waterinterface during brushing to form air bubbles or foam.

U.S. Pat. No. 4,647,451 (Colgate-Palmolive Company) describes anhydrousdentifrice compositions having desirable rheological, sensory andhygienic characteristics containing a polysaccharide gum and glycerinehumectant. According to U.S. Pat. No. 4,647,451, such compositionscomprise organic surface active agents which may be anionic, non-ionic,ampholytic, or cationic in nature. Compositions exemplified thereincontain sodium lauryl sulphate as the sole surfactant.

U.S. Pat. No. 5,670,137 (L'Oreal) describes a dentifrice compositioncontaining an anhydrous medium comprising glycerine, at least onehydroxyethylcellulose, at least one pyrogenetic silica. According toU.S. Pat. No. 5,670,137 such a composition also contains one or morefoaming surfactants which may be anionic, amphoteric, zwitterionic,cationic or non-ionic. Compositions exemplified therein contain sodiumlauryl sulphate as the sole surfactant.

WO96/03108 (SmithKline Beecham plc) and WO 2002/038119 (SmithKlineBeecham plc) both describe non-aqueous dentifrice compositions. Anionic,cationic, non-ionic and amphoteric surfactants are disclosed for use assuitable surfactants. A particularly preferred anionic surfactant isidentified as sodium methyl cocyl taurate, marketed under the name“Adinol CT 95”, this being the sole surfactant exemplified for use inthe compositions therein.

WO2005/063185 (Novamin Technology Inc.) describes non-aqueouscompositions of bioactive glass particulates in a non-aqueous carrier ofthe type disclosed in U.S. Pat. No. 5,882,630 (Gates). U.S. Pat. No.5,882,630 corresponds to the US patent derived from WO96/03108,discussed above. According to WO2005/063185, compositions therein mayoptionally comprise agents conventionally used in dentifriceformulations including, for example, a foaming agent such as sodiumlauryl sulphate. Compositions exemplified therein contain sodium laurylsulphate as the sole surfactant.

WO2010/115037 (Colgate-Palmolive Company) describes non-aqueouscompositions comprising carrageenan or a carboxymethylcellulose gum, ahumectant and a bioacceptable and bioactive glass. According toWO2010/1155037, compositions therein may comprise additivesconventionally used in dentifrice compositions including for example asurfactant such as sodium lauryl sulphate. Compositions exemplifiedtherein contain sodium lauryl sulphate as the sole surfactant.

Whilst the non-aqueous compositions described in the prior art addresssome of the problems encountered with formulating dentifrice additivesthat are incompatible with aqueous-based systems, there neverthelessremains a need for alternatives. Ideally such alternative compositionsshould further demonstrate one or more properties that are key driversof consumer acceptance including, for example, havingconsumer-acceptable organolpetic properties. Ideally the organolepicproperties of such a composition will be at least as good as orpreferably improved over those seen in comparable, marketed non-aqueousdentifrice products.

It is an object of the invention to provide such a composition.

SUMMARY OF THE INVENTION

In one aspect the invention provides a non-aqueous dentifricecomposition comprising a carrier wherein the carrier consists of asurfactant system consisting of a first surfactant which is a betaine incombination with a second surfactant which is a taurate or an alkylsulphate or mixtures thereof.

Surprisingly it has been discovered that a non-aqueous compositioncomprising a surfactant system consisting of a combination ofsurfactants, specifically a betaine and a taurate, or a betaine and anC₁₀₋₂₀ alkyl sulphate, provides significantly superior organolepticproperties compared to that observed for a composition comprising asingle, sole surfactant (sodium lauryl sulphate). Such superiororganoleptic properties include one or more of improved mouthfeel,improved foam dispersion and consistency, and improved foamcharacteristics such as intensity and density, all of which are desiredattributes in a dentifrice composition. In some embodiments foamcharacteristics are improved without modifying significantly on tasteproperties.

DETAILED DESCRIPTION OF THE INVENTION

As used herein, the term “non-aqueous” means anhydrous or substantiallyfree of water. The individual components of the non-aqueous compositionmay contain limited amounts of water as long as the overall compositionremains substantially free of water.

As used herein the term “dentifrice” includes any semi-solid preparationin the form of a paste, cream or gel for use in cleaning all or aportion of the oral cavity of an individual.

As used herein the term “oral cavity” means an individual's teeth andgums including all periodontal regions including teeth down to thegingival margins and/or the periodontal pockets.

A composition according to the invention comprises a surfactant system.The surfactant system consists of a first surfactant and a secondsurfactant. In certain embodiments the surfactant system consists of afirst surfactant and a second surfactant wherein the second surfactantconsists of a mixture of surfactants.

A first surfactant for use in the surfactant system of a compositionaccording to the invention belongs to the class of compounds known asbetaines. Structurally, betaine compounds contain an anionic functionalgroup such as a carboxylate functional group and a cationic functionalgroup such as quaternary nitrogen functional group separated by amethylene moiety. They include n-alkyl betaines such as cetyl betaineand behenyl betaine, and n-alkylamido betaines such as cocoamidopropylbetaine. In one embodiment the betaine is cocoamidopropyl betaine,commercially available under the trade name Tego Betain. Suitably thebetaine is present in an amount ranging from about 0.05 to about 4% byweight of the non-aqueous composition, for example from about 0.2 toabout 2.0% by weight of the non-aqueous composition.

A second surfactant for use in the surfactant system of a compositionaccording to the invention is selected from a taurate or a C₁₀₋₂₀ alkylsulphate surfactant. Taurate surfactants useful in the present inventionare salts of fatty acid amides of N-methyl taurine. They conformgenerally to the structural formula:RC(O)N(CH₃)CH₂CH₂SO₃M

Where RC(O)— represents a fatty acid radical and M represents sodium,potassium, ammonium or triethanolamine. Fatty acids having carbon chainlengths of from 10 to 20, including those derived from coconut, palm andtall oil are used. In one embodiment the fatty acid is derived fromcoconut. In one embodiment, sodium salts are used. In one embodiment thetaurate is sodium methyl cocyl taurate. This taurate surfactant is soldunder the trademark by Adinol CT by Croda.

The taurate surfactant may be present in an amount from about 0.1 toabout 10% of the non-aqueous composition. In one embodiment the tauratesurfactant is present in an amount from about 0.1 to about 5% by weightof the non aqueous composition. In one embodiment the taurate surfactantis present in an amount from about 0.5 to about 2.0% by weight of thenon-aqueous composition.

Alkyl sulphate surfactants of use in the invention have the followingstructural formula:R¹OSO₃M

R¹ represents a fatty alcohol moiety and M represents sodium, potassium,ammonium or triethanolamine. Fatty alcohols having carbon chain lengthsof from about 10 to about 20, including those derived from coconut, palmoil and tall oil. In one embodiment, the fatty alcohol is laurylalcohol. In one embodiment, a sodium salt is used. In one embodiment thealkyl sulphate is sodium lauryl sulphate.

The alkyl sulphate surfactant may be present in an amount from about 0.1to about 10% of the non-aqueous composition. In one embodiment the alkylsulphate surfactant may be present in an amount from about 0.1 to about5% by weight of the non aqueous composition. In one embodiment the alkylsulphate surfactant is present in an amount from about 0.5 to about 2.0%by weight of the non-aqueous composition.

In certain embodiments, the surfactant system consists of a firstsurfactant which is a betaine, and a second surfactant which consists ofa mixture of a taurate and a C₁₀₋₂₀ alkyl sulphate surfactant ashereinabove described. In one embodiment the surfactant system consistsof a first surfactant which is a betaine and second surfactant whichconsists of a mixture of sodium methyl cocyl taurate and sodium laurylsulphate.

In one aspect a composition according to the invention comprises adentifrice additive that is unstable or incompatible with an aqueousenvironment.

An example of such an additive is a bioactive glass of the typedisclosed in WO96/10985, WO 97/27158 and WO 99/13852. In an aqueousenvironment such a bioactive glass releases ions causing a significantincrease in pH which can adversely affect the stability (especially uponlong-term storage) of any excipients contained within the dentifrice.Formulating a bioactive silica-based glass in the non-aqueous dentifriceof the present invention prevents the release of ions within thedentifrice thereby controlling pH and increasing long-term storagestability of the dentifrice.

In one embodiment the bioactive glass for use in the invention has acomposition consisting of about 45% by weight silicon dioxide, about24.5% by weight sodium oxide, about 6% by weight phosphorus oxide, andabout 24.5% by weight calcium oxide. One such bioactive glass isavailable commercially under the trade name, NovaMin®, also known as45S5 Bioglass®.

The bioactive glass is present in an amount ranging from about 1 toabout 20% by weight of the non-aqueous composition. In one embodiment,the bioactive glass is present in an amount from about 1 to about 15% byweight of the non-aqueous composition. In an alternative embodiment, thebioactive glass in the non-aqueous composition is present in an amountfrom about 1 to about 10% by weight of the non-aqueous composition. In afurther alternative embodiment the bioactive glass is present in anamount from about 2 to about 8% by weight of the non-aqueouscomposition.

In one embodiment of the invention, a dentifrice composition is preparedcomprising the following components in percent by weight:

Bioactive glass about 1 to about 10 Betaine about 0.05 to about 4Taurate about 0.5 to about 2 Carbomer about 0.3 to about 1 Glycerinabout 50 to about 70 Polyethylene glycol about 15 to about 25

In one embodiment of the invention, a dentifrice composition is preparedcomprising the following components in percent by weight:

Bioactive glass about 1 to about 10 Betaine about 0.05 to about 4 SLSabout 0.5 to about 2 Carbomer about 0.3 to about 1 Glycerin about 50 toabout 70 Polyethylene glycol about 15 to about 25

The carrier comprising the surfactant system is a non-aqueous carrierand is substantially non-reactive with bioactive glass particulates (orother dentifrice additives that are unstable or incompatible with anaqueous environment) and is suitable for use in a dentifricecomposition. Suitable non-aqueous carrier formulations are described,for example, in U.S. Pat. No. 5,882,630, issued to Gates et al. (1999).

A non-aqueous carrier useful in the present invention typicallycomprises a thickening agent and one or more formulation solvent(s).Optionally, a dentally acceptable abrasive may be included in thenon-aqueous carrier.

Advantageously, a thickening agent is present in the formulation to givethe product a rheology closer to that of a conventional dentifrice.Suitably the thickening agent comprises a carboxyvinyl polymer such as acarbomer. A carbomer comprises synthetic high molecular-weightcross-linked polymers of acrylic acid. The polymer chains formed ofrepeating units of acrylic acid may be cross-linked with, for example:allyl sucrose to provide a carbomer available commercially in one formas Carbopol™ 934; ethers of pentaerythritol to provide a carbomeravailable commercially in one form as Carbopol™ 974; or with divinylglycol, available commercially in one form as Noveon™ AA-1. Carbopol™polymers are manufactured by B.F. Goodrich Company. In one embodimentthe carboxyvinyl polymer comprises Carbopol™ 974. The carboxyvinylpolymer may be present in the range of from about 0.1 to about 7.5% byweight of the non-aqueous composition. In one embodiment thecarboxyvinyl polymer is present in an amount from about 0.3 to about1.0% by weight of the composition.

Suitably a composition according to the invention may further comprisean inorganic thickening agent such as a thickening silica. Suitably, thethickening agent is a thickening silica, for example, a colloidalhydrated silica, available commercially for example as Sident 22S orSyloid 244FP.

In one embodiment the thickening silica is present in the range of fromabout 0 to about 15%, suitably from about 5.0 to about 15.0% by weightof the non-aqueous composition.

Suitable solvents for use in the present invention include glycerin,sorbitol, propylene glycol, polyethylene glycol or mixtures thereof. Inone embodiment the solvent comprises glycerin. It is well known thatcommercially available glycerin may contain between 0.1-2.0% by weightof water which is in association with the glycerin. Typically thisamount is <0.5% for example between 0.1-0.5% by weight of the glycerin.This small amount of water is bound to the glycerin and is therefore notavailable to the other ingredients. The skilled person would stillconsider a composition containing glycerin as being non-aqueous. Thesolvent should in any case be as anhydrous as possible.

In one embodiment the solvent comprises polyethylene glycol. Suitably,the polyethylene glycol will be selected from PEG 300, PEG 400 andmixtures thereof. In one embodiment the polyethylene glycol comprisesPEG 400.

In one embodiment the solvent comprises a mixture of glycerin andpolyethylene glycol.

The formulation solvent is used to make the formulation up to 100%, andsuitably the total amount of solvent may be present in the range of fromabout 20 to about 95% by weight of the non-aqueous composition.

Suitably the solvent comprises glycerin present from about 35 to about75%. In one embodiment the glycerin is present from about 50 to about70% by weight of the non-aqueous composition.

Suitably the solvent comprises polyethylene glycol present from about0.1% to about 40% by weight of the non aqueous composition. In oneembodiment the polyethylene glycol is present from about 15 to about 25%by weight of the non-aqueous composition.

In order to produce a composition that is smooth and does not show anysigns of stickiness, use of a particular ratio of carboxyvinyl polymerto polyethylene glycol is desirable.

Advantageously, the ratio of carboxyvinyl polymer to polyethylene glycolis in the range of about 1:15 to about 1:30.

A dentally acceptable abrasive may optionally be added to thenon-aqueous composition. Advantageously, the presence or absence of adentally acceptable abrasive as well as the amount of such abrasive maybe used to selectively control the abrasivity of the dentifricecomposition made with the non-aqueous compositions of the invention. Byway of example, and if present, the bioactive glass may provide anacceptable amount of abrasivity for the non-aqueous compositiondepending upon the ultimate use. By further way of example, a desiredamount of dentally acceptable abrasive may be added to increase theabrasivity of the overall non-aqueous composition.

Suitable abrasives for use in the non-aqueous composition include, forexample, amorphous, gelled, precipitated or fumed silica, zincorthophosphate, sodium bicarbonate (baking soda), plastic particles,alumina, hydrated alumina, calcium carbonate, calcium pyrophosphate,insoluble metaphosphates or mixtures thereof.

The silica abrasive may be a natural amorphous silica, for instancediatomaceous earth; or a synthetic amorphous silica such as aprecipitated silica. By way of example, silica abrasives include thosemarketed under the following trade names Zeodent, Sident, Sorbosil orTixosil by Huber, Degussa, Ineos and Rhodia respectively.

Suitably a silica abrasive is present in an amount up to 25% by weightof the total composition, for example from 2 to 20% by weight forexample from 5 to 15% by weight of the total composition.

Generally, an amount of abrasive suitable for use in the non-aqueouscomposition of the present invention will be empirically determined toprovide an acceptable level of cleaning and polishing, in accordancewith the techniques well known in the art. Suitably, the abrasive ispresent in an amount from about 0 to about 60%, typically from about 5to about 30%, by weight of the non-aqueous composition.

The non-aqueous compositions of the invention may additionallyoptionally contain one or more oral care active agents conventionallyused in dentifrice formulations. Such agents may include, by way ofexample, a fluoride source, a desensitizing agent, an anti-calculusagent, an anti-erosion agent, an antimicrobial agent, an anti-plaqueagent, a whitening agent, an oral malodour agent or a mixture of atleast two thereof.

Suitable sources of fluoride ions for use in the compositions of thepresent invention include an alkali metal fluoride such as sodiumfluoride, an alkali metal monofluorophosphate such a sodiummonofluorophosphate, stannous fluoride, or an amine fluoride in anamount to provide from 25 to 3500 pm of fluoride ions, preferably from100 to 1500 ppm.

In addition to or as an alternative to the bioactive glass, a furtherdesensitizing agent, including a tubule blocking agent or a nervedesensitizing agent and mixtures thereof, for example as described in WO02/15809 (Block) may be included in a composition according to theinvention. Such further optional desensitizing agent(s) include astrontium salt such as strontium chloride, strontium acetate orstrontium nitrate or a potassium salt such as potassium citrate,potassium chloride, potassium bicarbonate, potassium gluconate andespecially potassium nitrate.

Polyphosphates are known to help retard calculus formation and areexamples of anticalculus agents suitable for use in the invention. Apolyphosphate is generally understood to consist of two or morephosphate groups arranged primarily in a linear configuration, althoughsome cyclic derivatives may be present. Polyphosphates of use in theinvention include pyrophosphates, polyphosphates having three or morepolyphosphate groups such as sodium tripolyphosphate, and polyphosphateshaving four or more polyphosphate groups such as tetrapolyphosphate andhexametaphosphate among others.

Compositions of the invention may further comprise an antierosion agent,for example a polymeric mineral surface active agent as described in WO04/054529 (Procter & Gamble).

Compositions of the present invention will contain additionalformulating agents such as flavouring agents, sweetening agents,opacifying or colouring agents and preservatives, selected from thoseconventionally used in an oral hygiene composition art for suchpurposes.

In general, the optional agents may be used in a minor amount orproportion of the overall formulation. By way of example, suchcomponents are usually present in from about 0.001 to about 5% by weightof the non-aqueous composition.

The dentifrice composition typically has a viscosity suitable forapplication to the oral cavity. The viscosity will vary depending on thetype of dentifrice composition made and the ultimate use thereof. One ofskill in the art can readily prepare compositions with suitableviscosities for use in the oral cavity from the teachings providedherein.

The compositions according to the present invention may be prepared byadmixing the ingredients in the appropriate relative amounts in anyorder that is convenient.

The invention is further illustrated by the following Examples.

Example 1 Non-aqueous Composition (Betaine with Taurate)

Ingredient Function % w/w Glycerol Formulation Solvent 58.39Polyethylene Glycol 400 Formulation Solvent 20.00 Silicon DioxideThickener 10.00 NovaMin Desensitising Agent 5.00 Cocamidopropyl BetaineFoaming Agent 1.20 Sodium Methyl Cocoyl Taurate Foaming Agent 1.20Sodium Monofluorophosphate Oral Heath Active Agent 1.08 Titanium DioxideOpacifier 1.00 Carbomer Homopolymer Thickener 0.75 Sodium SaccharinSweetener 0.35 Flavour Flavour 1.03

Example 2 Non-aqueous Composition (Betaine with Alkyl Sulphate)

Ingredient Function % w/w Glycerol Formulation Solvent 59.33Polyethylene Glycol 400 Formulation Solvent 20.00 Silicon DioxideThickener 10.00 NovaMin Desensitising Agent 5.00 Cocamidopropyl BetaineFoaming Agent 0.36 Sodium Lauryl Sulphate Foaming Agent 1.10 SodiumMonofluorophosphate Oral Heath Active Agent 1.08 Titanium DioxideOpacifier 1.00 Carbomer Homopolymer Thickener 0.75 Sodium SaccharinSweetener 0.35 Flavour Flavour 1.03

Example 3 Sensory Evaluation of Non-aqueous Compositions of theInvention

Study Objectives

The objectives of these studies were to evaluate the texture profile ofseveral detergent systems.

1. Study 1—Attribute Diagnostic Tests

The dentifrice compositions evaluated included control formulations 1-3(containing SLS as the sole surfactant component) and dentifricecompositions according to the invention, D1-D2.

Ingredient Control 1 Control 2 Control 3 D1 D2 Glycerol 62.77 62.5762.37 62.41 61.47 Sodium Lauryl 1.10 1.30 1.50 1.10 — SulphateCocoamidopropyl — — — 0.36 1.20 Betaine Sodium Methyl — — — — 1.20Cocoyl Taurate Polyethylene Glycol 20.00 20.00 20.00 20.00 20.00 400Silicon Dioxide 8.00 8.00 8.00 8.00 8.00 NovaMin 5.00 5.00 5.00 5.005.00 Titanium Dioxide 1.00 1.00 1.00 1.00 1.00 Carbomer 0.75 0.75 0.750.75 0.75 Homopolymer Sodium Saccharin 0.35 0.35 0.35 0.35 0.35 Flavour1.03 1.03 1.03 1.03 1.03

The sensory attributes evaluated were: texture attribute (foamintensity, foam consistency, foam dispersion, foam density); clean teethsensation and overall liking of the mouthfeel. Seven panellists from theproject team were recruited. Samples were blinded, labelled with athree-digit number and presented randomly to the panellists. Nostatistical analysis was applied due to the low number of panellists.

The samples were perceived as follows:

Foam systems (concentration % w/w) D1 D2 Control 1 Control 2 Control 31.1% SLS- 1.2% AD- 1.1% SLS 1.3.% SLS 1.5% SLS 0.36% TB 1.2% TBMouthfeel 5.5 5.2 4.8 5.6 5.0 liking like like slightly like slightlylike like slightly slightly moderately Dispersion of 3.8 3.7 3.5 3.8 3.7the foam very easy very easy moderately very easy very easy easyConsistency of 2.5 2.3 2.6 2.8 2.6 the foam too thin too thin Just aboutJust about Just about right right right Foam intensity 2.9 2.8 3.4 3.64.6 moderately moderately very foaming very foaming extremely foamingfoaming foaming Foam density 2.4 2.7 2.7 3.0 2.7 slightly moderatelymoderately moderately moderately dense dense dense dense dense Cleanteeth 4.1 4.0 4.0 4.0 4.4 sensation very clean very clean very cleanvery clean very clean2. Study 2—Descriptive Profile of the AD/TB and SLS/TB

The objectives of the study were to obtain a complete comparison of thetaste and mouthfeel profile of toothpaste formulations (D1 and D2referred to above) versus a control formulation−Control 4 (1.1% w/wSLS).

The formulation details of the Control 4 composition were as follows:

Glycerin 56.74 PEG 400 20.00 Silica 13.00 Calcium Sodium 5.00phosphosilicate Sodium Lauryl Sulphate 1.10 Sodium 1.08Monofluorophosphate Aroma # 1.03 Titanium Dioxide 1.00 Carbomer 0.70Potassium Acesulfame 0.35

Samples were blinded, labelled with a three-digit number and presentedrandomly to fifteen professional panellists.

The sensory attributes evaluated were texture attributes (foamintensity, foam density, foam dispersion, smoothness) and tasteattributes (sweetness intensity, bitterness intensity; flavourintensity) and clean teeth sensation. The organoleptic profiles of thesamples were perceived as follows:

Control D1 D2 4 1.1% w/w 1.2% w/w 1.1% SLS − AD − Sensory w/w 0.36% w/w1.2% w/w attributes SLS TB p-value TB p-value Foam 34.8 43.3 p < 0.00149.1 p < 0.001 intensity Foam 20.6 20.8 Ns 27.6 p < 0.001 densityDispersion 45.6 42.7 Ns 49.5 p < 0.001 of the paste Smoothness 41.4 40.0Ns 39.5 Ns of the paste Flavour 52.1 59.1 p < 0.001 57.0 p < 0.001intensity Bitterness 30.7 28.1 p = 0.05 26.1 p < 0.001 Sweetness 24.326.0 p < 0.05 22.4 Control is sweeter at p < 0.05 Clean 59.3 65.0 p <0.005 61.3 p = 0.06 sensationConclusion:

Tego Betain/Adinol and Tego Betain/SLS detergent systems improved thefoam characteristics of the compositions relative to the SLS systemalone, without modifying significantly taste characteristics. The TegoBetain/Adinol composition provided the best performance in terms offoam.

Study 3—Descriptive Profiles of Single Formulations and MixedCombinations of Tego Betain (TB) and Adinol (AD)

The objectives of the study were to identify and quantify differences intextural elements between formulations comprising SLS, Tego Betain orAdinol as the sole surfactant, and formulations comprising a combinationof surfactants i.e. Tego Betain/Adinol and Tego Betain/SLS.

The composition of the toothpastes tested was as follows.

TB/AD TB/SLS TB SLS AD Material % w/w % w/w % w/w % w/w % w/w Glycerin59.47 60.27 60.67 60.67 60.67 Polyethylene Glycol 400 20.00 20.00 20.0020.00 20.00 Silicon Dioxide 10.00 10.00 10.00 10.00 10.00 NovaMin 5.005.00 5.00 5.00 5.00 Cocoamidopropyl 1.20 0.40 1.20 N/A N/A Betaine (TegoBetain) Sodium Methyl Cocoyl 1.20 N/A N/A N/A 1.20 Taurate (Adinol)Sodium Lauryl Sulfate N/A 1.20 N/A 1.20 N/A Titanium Dioxide 1.00 1.001.00 1.00 1.00 Carbomer 0.75 0.75 0.75 0.75 0.75 Sodium Saccharin 0.350.35 0.35 0.35 0.35 Flavour 1.03 1.03 1.03 1.03 1.03 Total 100.00 100.00100.00 100.00 100.00

Samples were blinded, labelled with a three-digit number and presentedrandomly to fifteen professional panellists.

Five sensory attributes describing the mouthfeel characteristics of thetoothpastes were evaluated. The attributes were: foam intensity, foamdensity, foam consistency, foam dispersion and lathering of the foam.ANOVA with α=5% was applied and LSD were calculated to establish anysignificant difference between the samples and control.

The organoleptic profiles of the samples were perceived as follows:

Mixed Single Combinations formulations 0.4% 1.2% 1.2% 1.2% 1.2% w/w TB +w/w TB + Sensory w/w w/w w/w 1.2% w/w 1.2% w/w attributes SLS TB AD SLSAD Foam 46.87 48.52 ns 48.44 ns 63.19* 65.33* Intensity Foam 34.69 30.96ns 33.17 ns 44.00* 43.88* Density Foam 18.86 23.13 ns 26.68* 33.04*37.95* consistency Lathering 63.20 65.47 ns 66.00 ns 75.87* 75.91*effect Dispersion 34.12 34.97 ns 33.47 ns 35.78 ns 36.74 ns of the pastens = no significant difference between the toothpaste formulations andthe SLS formulation *= significant difference (p < 0.001) between thetoothpaste formulations and the SLS formulation

-   -   The formulation with 1.2% w/w Tego Betain was not significantly        different from the formulation with 1.2% w/w SLS in terms of        foam intensity, foam density, foam consistency and lathering of        foam.    -   The formulation with 1.2% w/w Adinol was not significantly        different from the formulation with 1.2% w/w SLS in terms of        foam intensity, foam density and lathering of foam, but had a        foam consistency significantly (p<0.001) thicker.    -   The foam characteristics (intensity, density, consistency and        lathering) of a 1.2% w/w SLS formulation with 0.4% w/w of Tego        Betain was significantly (p<0.001) better than those of a        formulation with 1.2% w/w SLS only.    -   The foam characteristics (intensity, density, consistency and        lathering effect) of a 1.2% w/w Tego Betain formulation with        1.2% w/w Adinol was significantly (p<0.001) better than those of        a formulation with 1.2% w/w SLS only.    -   There was no significant difference between the single        formulations and the mixed combinations and the 1.2% w/w SLS        control with regards to the dispersion of the foam during        brushing.    -   Overall the mixed combinations were significantly (p<0.001)        foamier than the single formulations. The foam of these dual        detergent systems was thicker with small bubbles and the foam        appeared soon after the start of the brushing. There was no        difference in terms of foam characteristics within the single        formulations or the mixed combinations.        Conclusions:    -   In terms of foam characteristics, there was parity between        toothpaste formulations with 1.2% w/w SLS or 1.2% w/w Tego        Betain. A 1.2% w/w Adinol formulation also had the same foaming        characteristics (intensity, density and lathering) except the        foam consistency was thicker.    -   The addition of Tego Betain (0.4% w/w) to a 1.2% w/w SLS        formulation significantly (p<0.001) improved the foam        characteristics of the toothpaste. The paste was foamier and the        foam had a better quality (thicker with smaller bubbles) and the        toothpaste foamed at the start of the brushing (lathering).    -   Toothpaste formulations with an Adinol/Tego Betain blend were        significantly foamier than formulations with SLS only. The foam        was thicker with smaller bubbles and the toothpaste foamed soon        after the start of the brushing.    -   The degree to which the foam spread all around the mouth        (dispersion of the foam) was not influenced by the composition        of the detergent system.

What is claimed is:
 1. A non-aqueous dentifrice composition comprising anon-aqueous carrier wherein the carrier comprises: glycerin in an amountfrom 50% to 70% by weight of the composition; polyethylene glycol in anamount from 15 to 25% by weight of the composition; a thickening agentconsisting of from 0.3% to 1.0% by weight of the composition of acarboxyvinyl polymer and from 5.0 to 15.0% by weight of the compositionof a thickening colloidal hydrated silica; and a surfactant systemconsisting of a first surfactant which is a betaine in an amount from0.05% to about 0.4% by weight of the composition and a second surfactantwhich is sodium lauryl sulphate in an amount from 0.5 to 1.5% by weightof the composition.
 2. The composition according to claim 1 wherein thebetaine is cocoamidopropyl betaine.
 3. The composition according toclaim 1 comprising an oral care active agent selected from a fluoridesource, a desensitizing agent, an anti-calculus agent, an anti-erosionagent, an antimicrobial agent, an anti-plaque agent, a whitening agent,an oral malodour agent or a mixture of at least two thereof.